Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2003 to 15 August 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2003-08-29
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation, public health

C 204/6

EN

Official Journal of the European Union

29.8.2003

— Issuing of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

22.7.2003

Gonazon

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/03/040/001

24.7.2003

— Modification of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

22.7.2003

Dicural

22.7.2003

Metacam

1.8.2003

Metacam

1.8.2003

Metacam

Fort Dodge Animal Health Holland
C. J. van Houtenlaan 36
1381 CP Weesp
Nederland

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/003/001-018

24.7.2003

EU/2/97/004/003-005

24.7.2003

EU/2/97/004/003-005

5.8.2003

EU/2/97/004/007-008

5.8.2003

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 July 2003 to 15 August 2003

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

— Lift of suspension of a marketing authorization

(2003/C 204/03)

Date of
the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

14.7.2003

Felodipine

See Annex

See Annex

15.7.2003

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, APPLICANTS, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

MR procedure DE/H/0358/001-003

Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

DENMARK

GERMANY

Alpharma AS
Harbitzalléen 3
Post Box 158
Skoyen
NO-0212 Oslo

Alpharma AS
Harbitzalléen 3
Post Box 158
Skoyen
NO-0212 Oslo

Alpharma-ISIS
GmbH & Co. KG
Elisabeth-Selbert-Straße 1
D-40764 Langenfeld

Alpharma-ISIS
GmbH & Co. KG
Elisabeth-Selbert-Straße 1
D-40764 Langenfeld

Felodipin
Alpharma

5 mg

Prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipin
Alpharma

10 mg

Prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28,
30, 50, 56, 60,
90, 98, 100, 250,
500, 1 000

14, 10, 20, 28,
30, 50, 56, 60,
90, 98, 100, 250,
500, 1 000

FELO-PUREN

10 mg

Prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

FELO-PUREN

5 mg

Prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

PORTUGAL

Alpharma ApS
Rua Virgílio Correia n.o 11A
P-1600-219 Lisboa

Felodipina
Alpharma

10 mg

Prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Alpharma ApS
Rua Virgílio Correia n.o 11A
P-1600-219 Lisboa

Felodipina
Alpharma

5 mg

Prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28,
30, 50, 56, 60,
90, 98, 100, 250,
500, 1 000

14, 10, 20, 28,
30, 50, 56, 60,
90, 98, 100, 250,
500, 1 000

.

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